Actively Recruiting
Volatility in Paranoia (VIP) Trial: An RCT of Changes in Volatility With Psychotherapy
Led by Vanderbilt University Medical Center · Updated on 2026-05-06
120
Participants Needed
1
Research Sites
263 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn whether learning and belief updating change in response to the treatment of persecutory delusions, in individuals with schizophrenia-spectrum disorders. The main questions are: 1. do prior expectations about environmental volatility reduce following effective psychotherapeutic treatment of delusions? 2. does corresponding brain activity related to volatility change with effective treatment of delusions? Participants will: 1. engage in CBTp or TAU + phone check-ins for 16 weeks 2. complete assessments at 4 timepoints over the course of 6 months 3. complete an MRI when possible
CONDITIONS
Official Title
Volatility in Paranoia (VIP) Trial: An RCT of Changes in Volatility With Psychotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women age 18 - 65.
- Communicative in English.
- Premorbid IQ >79 (WTAR).
- Provide voluntary, written informed consent.
- Stable medication regimen over at least the past two weeks, including oral or intramuscular antipsychotic medication.
- Diagnosis of a non-affective psychotic disorder such as schizophrenia, schizoaffective disorder, schizophreniform disorder, or delusional disorder.
- Presence of a persecutory delusion scoring at least 3 on the conviction scale of the Psychotic Symptoms Rating Scale (PSYRATS) lasting at least two months and not due to substance use.
You will not qualify if you...
- Serious medical or neurological illness known to interfere with cognitive functioning (e.g., uncontrolled diabetes, uncontrolled hypothyroidism, Cushing's disease, Lupus, multiple sclerosis, HIV infection, CNS infection, unstable heart disease, active hepatitis, significant endocrine conditions, CNS/brain cancer, uncorrected vision problems, tardive dyskinesia).
- History of severe head trauma with loss of consciousness longer than 30 minutes.
- Primary diagnosis of alcohol or substance use disorder or personality disorder.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Actively Recruiting
Research Team
J
Julia Sheffield, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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